Gilead Announces Results from Study of Sovaldi® for Retreatment of Chronic Hepatitis C in Patients Not Cured with Prior

  Gilead Announces Results from Study of Sovaldi® for Retreatment of Chronic
  Hepatitis C in Patients Not Cured with Prior Antiviral Therapy

   -- Results Demonstrate Efficacy of Sovaldi-Based Regimen in GT1 Infected
   Patients Who Failed Prior Therapy with Other Direct Acting Antivirals--

-- Data Support Retreatment with Sovaldi-Based Regimen in GT2 or GT3 Infected
             Patients Who Failed Prior Treatment with Sovaldi --

The International Liver Congress 2014

Business Wire

LONDON -- April 10, 2014

Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from an
open-label clinical trial (Study GS-US-334-0109) evaluating once-daily
Sovaldi^® (sofosbuvir) 400 mg tablets for the retreatment of chronic hepatitis
C virus (HCV) infection among patients who failed prior therapy. These data
will be presented in two oral sessions at the 49th Annual Meeting of the
European Association for the Study of the Liver (The International Liver
Congress 2014) in London.

In Study GS-US-334-0109 (Oral #55), patients with genotype 1 HCV infection
(n=80) received 12 weeks of treatment with once-daily Sovaldi plus
weight-based ribavirin (RBV) twice-daily (1,000 or 1,200 mg/day) and pegylated
interferon (peg-IFN; 180 μg/week). Patients in the study had failed prior
regimens containing peg-IFN, RBV and an investigational NS3 protease
inhibitor, with or without investigational direct-acting antivirals (DAAs)
(NS5A and/or non-nucleoside NS5B inhibitors). Forty-five percent of patients
(n=36) had received more than one course of prior therapy, and 90 percent
(n=72) had at least one viral mutation associated with HCV NS3, NS5A or NS5B
drug resistance.

Among the 50 patients for whom sustained virologic response data was available
12 weeks after the end of treatment (SVR12), 74 percent (n=37/50) achieved
SVR12. Additionally, 80 percent (n=28/35) of patients with baseline resistance
against two or more DAAs achieved SVR12.

“This study demonstrates that Sovaldi-based regimens can achieve high cure
rates even among hepatitis C patients who previously failed therapy with
baseline resistance to at least two DAAs,” said Stanislas Pol, MD, PhD,
Professor of Hepatology and Gastroenterology, Paris Descartes University,
Paris, France, and a principal investigator. “Importantly, Sovaldi has now
demonstrated efficacy among genotype 1 HCV infected patients who failed prior
treatment with three or four drug regimens and have developed viral resistance
to some of the components of those regimens.”

In a separate presentation (Oral #8), retreatment with Sovaldi in genotype 2
(n=11) or genotype 3 (n=96) HCV infected patients who previously failed
treatment with 12 or 16 weeks of Sovaldi plus RBV in the Phase 3 studies
FISSION, FUSION and POSITRON was evaluated. Thirty-six percent of these
patients (39/107) had cirrhosis. Patients were retreated either with a 12-week
regimen of Sovaldi, RBV and peg-IFN, or a 24-week, interferon-free regimen of
Sovaldi plus RBV. The choice of regimen was determined by study investigators.

Among patients with available SVR12 data, 63 percent (n=25/40) of those who
received the 24-week all-oral regimen and 92 percent (n=24/26) of those who
received the 12-week regimen of Sovaldi, RBV, and peg-IFN achieved SVR12.

“These data support initial findings from the Phase 3 trials, which
demonstrate that Sovaldi is an effective treatment option and one that may
also be particularly important for genotype 2 and 3 patients who failed a
previous sofosbuvir-based regimen,” said Rafael Esteban, MD, Head of the
Internal Medicine and Liver Unit, Hospital Universitari Vall d’Hebron and
Professor of Medicine, Universitat Autónoma de Barcelona, Barcelona, Spain and
a principal investigator for the study.

Sovaldi was well tolerated in Study GS-US-334-0109. The most common adverse
events were consistent with the safety profiles of peg-IFN and/or RBV.
Additional information about the study can be found at

About Sovaldi

Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B polymerase
enzyme, which plays an essential role in HCV replication. Sovaldi is a
direct-acting agent, meaning that it interferes directly with the HCV life
cycle by suppressing viral replication.

Sovaldi ^ was approved in the United States on December 8, 2013 and in the
European Union on January 17. In the United States, Sovaldi is approved for
the treatment of chronic hepatitis C infection as a component of a combination
antiviral treatment regimen. Efficacy has been established in subjects with
HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular
carcinoma meeting Milan criteria (awaiting liver transplantation) and those
with HCV/HIV-1 co-infection. Treatment response varies based on baseline host
and viral factors. Monotherapy is not recommended for treatment of chronic
hepatitis C. Study GS-US-334-0109 evaluated investigational uses of Sovaldi,
for which safety and efficacy have not yet been established.



Sovaldi combination treatment with ribavirin or with peginterferon alfa plus
ribavirin is contraindicated in women who are pregnant or may become pregnant
and men whose female partners are pregnant because of the risk for birth
defects and fetal death associated with ribavirin. Contraindications to
peginterferon alfa and ribavirin also apply to Sovaldi combination treatment.
Refer to the prescribing information of peginterferon alfa and ribavirin for a
list of their contraindications.

Warnings and Precautions

  *Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin
    therapy should not be started unless a report of a negative pregnancy test
    has been obtained immediately prior to initiation of therapy. Female
    patients of childbearing potential and their male partners must use two
    forms of non-hormonal contraception during treatment and for at least 6
    months after treatment has concluded. Routine monthly pregnancy tests must
    be performed during this time. Refer to the prescribing information for

  *Use with Potent P-gp Inducers: Rifampin and St. John’s wort should not be
    used with Sovaldi as they may significantly decrease sofosbuvir plasma
    concentration, reducing its therapeutic effect.

Adverse Reactions

Most common (≥20 percent, all grades) adverse reactions for:

  *Sovaldi + peginterferon alfa + ribavirin combination therapy were fatigue,
    headache, nausea, insomnia, and anemia
  *Sovaldi + ribavirin combination therapy were fatigue, and headache

Drug Interactions

In addition to rifampin and St. John’s wort, coadministration of Sovaldi is
not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin,
rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is
expected to decrease the concentration of sofosbuvir, reducing its therapeutic

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and
commercializes innovative therapeutics in areas of unmet medical need. The
company’s mission is to advance the care of patients suffering from
life-threatening diseases worldwide. Headquartered in Foster City, California,
Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that are subject to
risks, uncertainties and other factors, including the possibility of
unfavorable longer-term results from clinical trials evaluating Sovaldi for
the treatment or retreatment of HCV, and the risk that healthcare providers,
payers or insurers may not recognize the benefits of Sovaldi. As Sovaldi is
used over longer periods of time by treatment-experienced patients with
underlying health problems taking numerous other medicines, Gilead may find
new issues such as safety, resistance or drug interaction issues, which may
require it to provide additional warnings or contraindications in the label,
which could reduce the market acceptance of Sovaldi. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements. These and
other risks are described in detail in Gilead’s Annual Report on Form 10-K for
the year ended December 31, 2013, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.

U.S. full prescribing information for Sovaldi is available at

          Sovaldi is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead Sciences, please visit the company’s website at, follow Gilead on Twitter (@GileadSciences) or call Gilead
             Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.


Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936 (Investors)
Cara Miller, +1 650-522-1616 (Media (U.S.))
Arran Attridge, +44 208 587 2477 (Media (Europe))
Press spacebar to pause and continue. Press esc to stop.